Clinical Trial

Regulatory T Cells for Amyotrophic Lateral Sclerosis

Study acronym: REGALS
Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated April 11, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
Summary
Phase 1 Safety Run-in Study of 6 patients followed by Phase 1b Randomized, Double Blind, Placebo Control Trial of CK0803, neurotropic, allogeneic, umbilical cord blood derived T regulatory (Treg) cells in additional 60 patients with Amyotrophic Lateral Sclerosis.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2023-01-23; most recent amendment 2025-04-09.
Status change: Recruiting → Active, Not Recruiting 2025-04-09
Status change: Not Yet Recruiting → Recruiting 2023-04-05
Trial Details
NCT Number NCT05695521
Lead Sponsor Cellenkos, Inc.
Conditions Amyotrophic Lateral Sclerosis
Enrollment 66 participants
Start Date 2023-04-03
Primary Completion 2026-05 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-11